Teva Canada Limited — FDA Facility Profile
Teva Canada Limited is an FDA-registered facility (FEI 3002807742) located in Markham, CA. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 6 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Apr 24, 2025: Voluntary Action Indicated (VAI)
- Inspections on record
- 6 (4 VAI, 2 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Import refusals
- 4
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Apr 24, 2025 | Voluntary Action Indicated (VAI) | Procedures not in writing, fully followed (21 CFR 211.22(d)) Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a)) Computer control of master formula records (21 CFR 211.68(b)) SOPs not followed / documented (21 CFR 211.100(b)) and 4 more |
| Apr 26, 2019 | No Action Indicated (NAI) | No citations listed |
| Nov 18, 2016 | Voluntary Action Indicated (VAI) | No citations listed |
| Feb 21, 2014 | No Action Indicated (NAI) | No citations listed |
| Sep 29, 2011 | Voluntary Action Indicated (VAI) | No citations listed |
| Jul 29, 2010 | Voluntary Action Indicated (VAI) | Containers & Closures Clean, Sterilized, Pyrogen-free (21 CFR 211.94(c)) Complaint Investigation/Follow-Up Findings (21 CFR 211.198(b)(2)) |
Facility details
- Company
- Teva Canada Limited
- Location
- Markham (CA)
- Registration Expires
- Dec 31, 2026
- Operations
- ANALYSIS; LABEL; MANUFACTURE; PACK
- Source
- decrs